JP2021531937A - Penis and other implants that promote tissue expansion - Google Patents

Abstract

The present invention relates to implants that promote tissue expansion without substantially impeding normal anatomical movements. The implant can be made of different materials or made of different configurations such that the measurement characteristics of the implant in the first position differ from the same measurement characteristics in the second position of the implant. In one particular embodiment, the implant can be an orthopedic penile implant. [Selection diagram] Fig. 1

Description

Mutual reference to related applications This application is filed in US Patent Application No. 62/702062 filed July 23, 2018, US Patent Application No. 62/779825 filed December 14, 2018, filed January 3, 2019. Claims the priority of US Patent Application No. 16/238821 and US Patent Application No. 16/238792 filed January 3, 2019. The above application is incorporated by reference for purposes for the United States.

Orthopedic implants such as thoracic implants and penile implants are becoming more popular. Similarly, prosthetic and other medical devices are increasingly being employed to treat or ameliorate conditions. For both implants and other medical devices, they are in existing tissue so that they have a similar appearance to the body part of the native human or animal or even an improved appearance to the body part of the native human or animal. It is often desired to adapt and / or mimic normal anatomical movements. Unfortunately, implants and devices made using conventional techniques do not promote tissue expansion, interfere with normal anatomical movements, and / or result in implants or devices that do not resemble the natural body part. There are many. Therefore, what is needed is an implant that achieves one or more of the above desired features.

Advantageously, the implants and medical devices of the present invention overcome the above problems. Implants usually consist of one or more biocompatible materials. Advantageously, in certain embodiments, the one or more materials may be selected or configured to promote tissue expansion without substantially impairing normal anatomical operation. Implants can also advantageously have an appearance that resembles or even improves on the natural body part. Therefore, the concept of the present invention is applicable to incontinence devices such as chest implants, penile implants, testicular implants, and other male or female urethral self-control plugs.

Due to the many limitations and drawbacks of currently available orthopedic penis strengthening devices, the above concepts can be particularly useful with respect to orthopedic penis implants. Some are equipped with a rigid, inelastic silicone block that increases the risk of external erosion, patient discomfort and unnatural loose penile appearance and sensation. Infection rates with currently available orthopedic penile implants are undoubtedly high, as neither is coated with antibody material or resistant to antibacterial agents. In addition, current orthopedic penile implants are implanted at the tip near the dorsal neurovascular bundle using non-absorbable sutures, which can cause penile necrosis or desensitization of the penis for penile resection and denervation. Brings the danger of. Also, stiff silicone blocks and non-absorbable sutures impede sufficient elasticity of the penis during erection, which can reduce sexual capacity during erection and cause discomfort.

Therefore, in one specific embodiment, the present invention relates to a penis implant. The penile implant generally has an outer and inner surface as well as a longitudinal axis and comprises a body of selected longitudinal length along the major axis of the penis. The body is on the longitudinal axis of the body with a layer thickness that thins in both opposite directions, starting from the maximum thickness along the dorsal centerline and to the minimum thickness along the ventral edge forming the ventral opening. It has a vertical cross section. Advantageously, the penile implant comprises one or more biocompatible materials selected or configured to promote tissue expansion.

The improved orthopedic penis implants of the present invention significantly reduce those adverse complications and protect the natural penile sexual function while providing a safer, more comfortable and more natural orthopedic penis enhancement. To the patient. Thus, subcutaneously implanted orthopedic penile implants can be configured to reproduce as close as possible to the native human anatomy in shape, appearance, elasticity, compressibility, texture and sensation.

These and other embodiments will be described in detail below.

FIG. 1 shows a perspective view of an embodiment of a penis implant. FIG. 2 shows a side view of the implant shown in FIG. FIG. 3 shows a cross-sectional view of the near end of the implant shown in FIG. FIG. 4 shows a cross-sectional view of the far end of the implant shown in FIG. FIG. 5 shows a far-end view of the implant shown in FIG. FIG. 6 shows a near-end view of the implant shown in FIG. FIG. 7 shows a cross-sectional view of the implant shown in FIG. FIG. 8 shows a cross section of the anatomy of the innate penis. FIG. 9A shows a perspective view of each side of the embodiment of the penis implant. FIG. 9B shows a perspective view of each side of the embodiment of the penis implant. FIG. 10 shows various representative dimensions of penile implants of various sizes. FIG. 11 shows typical mesh tab positions for the penile implants shown in FIGS. 9A and 9B. FIG. 12 shows the shore hardness scales and typical properties of various implants. FIG. 13 shows a selection of typical mesh materials. FIG. 14A shows embodiments of penile implant location, method and dimensional shape. FIG. 14B shows embodiments of penile implant location, method and dimensional shape. FIG. 14C shows embodiments of penile implant location, method and dimensional shape. FIG. 15 shows various configurations of the internal pockets of the implant core.

General Implants-Implants, Fabrication Methods, Materials, Compositions, (Orthopedic and Physical) Features, Description of Specific Implant Types As mentioned above, the implants and devices of the invention may be suitable for animals or humans. The specific singular or plural materials employed will vary depending on the specific implant, application, desired characteristics and the like. In many applications, the material employed is biocompatible, i.e., whether it is human or animal tissue, not particularly harmful to the tissue near or connected to the device or implant. No. As one or more materials usually promote tissue expansion without substantially interfering with normal anatomical movements and / or while substantially mimicking the characteristics of the flexible tissue of the natural body part. Selected, configured, or selected and configured. Of course, one or more materials and specific configurations selected will vary depending on the specific implant and desired tissue expansion and / or other outcome.

In one embodiment, in order to promote tissue expansion without substantially interfering with normal anatomical movement, the implant has a measurement characteristic at a first position on the implant at a second position on the implant. It comprises one or more biocompatible materials selected or configured to differ from the same measurement characteristics described above. Of course, when using the present invention, the measurement characteristics may differ at 3 or 4 or any number of positions on the implant. That is, the implant is, for example, the gradient observed as it travels from one point or position of the implant to another, i.e., the measurement properties (eg, hardness (durometer) and tensile strength, tear strength, compressive strength, and It may show an increase or decrease in the magnitude of extensibility), which may also be referred to as extensibility, extensibility or elasticity. This can be achieved with at least two general embodiments or a combination of the two embodiments.

First, the materials used may differ in the first, second and / or other additional positions of the implant. That is, the singular or plural materials employed may vary in the first, second and / or other positions of the implant with respect to the properties of interest for the implant. That is, the material of the implant may be, for example, one or more of the following properties (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength and (5) extensibility. It can differ with respect to 2 or more, 3 or more, 4 or more, or even 5 properties.

Making implants with different properties at different locations in the implant can be achieved in any suitable manner, for example, by using different materials with different properties. Such aspects will vary based on the implant, its properties, the materials used, and the desired characteristics.

Suitable methods may include molding, such as injection molding, extrusion, rotary molding, pressure molding, compression molding, blow molding, 3D printing and the like. In general, any suitable treatment may be employed as long as the desired material with the desired properties can be placed on and / or in the desired location within the implant. For example, when injection molding is used, a mold having a desired implant shape will be used. The mold may have multiple ejection points, eg, 2 or more, 3 or more, 4 or more, or the required or desired number of ejection points. In this aspect, different materials (or the same material with varying properties) may be ejected through each ejection port. If desired, there may be compartments within the mold, but compartments are often unnecessary as factors such as different injection points and injection timing can control the final placement of the various materials. In this aspect, the implant can be designed or adapted to have different properties at different locations or locations on or within the implant. Thus, desired properties such as (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength and (5) extensibility are the first location on the implant throughout the implant. It can be adapted by selecting one or more biocompatible materials such that the measurement characteristics in the implant differ from the same measurement characteristics as above at the second, third, fourth or additional positions of the implant. be.

A second method of making an implant, wherein the measurement characteristic at the first position on the implant is different from the same measurement characteristic at the second or further position, to achieve this. Accompanied by the steps of constructing the material in the implant. This second method can be used independently of the first method using a material that changes or one material that changes properties. Alternatively, the constructing steps further described below may be performed in combination with the use of varying materials or the use of one material with varying properties.

In one embodiment of this second method, one or more materials are configured to include one or more internal pockets within the implant. Such pockets are voids within the implant. The design and composition of the pocket, ie the void, will vary depending on the type of implant and the desired characteristics. For example, the geometry, size, depth and / or location of the implant's pocket can: (1) reduce the stiffness of at least a portion of the implant, (2) reduce the total weight of the implant, ( It can be configured to result in one or more of 3) increasing the extensibility (elasticity or extensibility) of at least a portion of the implant, or (4) increasing the compressibility of at least a portion of the implant. As a specific example, the internal pocket may comprise a pocket that modifies the measured compression or elongation on or within the implant, ie, a compression pocket, an extension pocket, or both. In a specific embodiment, the implant may be configured with, for example, an internal pocket that allows extensibility or extensibility. For example, in one embodiment, the implant is at least 10%, at least 20%, at least 40%, at least 60%, at least compared to the same implant substrate (eg, the same polymer of the same shape) that does not have an internal pocket. It may be configured with an internal pocket so that 80%, at least 100%, at least 150% or at least 200% elongation occurs. Implants, on the other hand, are up to 500%, up to 450%, up to 400%, up to 350%, up to 300% or up to 250 compared to the same implant substrate without internal pockets (eg, the same polymer of the same shape). May be configured with an internal pocket so that stretch up to% occurs. Stretching means stretching in one direction or compressing in the other.

As mentioned above, the particular geometry of the internal pocket can vary widely depending on the desired result. In certain embodiments, the implant can be designed such that the implant's internal pockets can be honeycomb (eg, polygons such as hexagons), zigzag (WWWWWW) or even elliptical configurations. Thus, the implant can be made such that the measurement characteristics of the implant at the first location differ from the same measurement characteristics at the second, third, fourth or additional positions of the implant. For example, the hardness of an implant at a particular location will usually depend at least to some extent on the nature and volume of the pocket or void beneath that location. That is, the larger the volume of the void below a particular implant position, the softer the implant will feel at that particular position. Thus, the implant has a low density honeycomb structure at the near end and a high density honeycomb structure or gradient or gradual honeycomb density at the far end, with different hardness and / or different hardness and / or across various dimensions of the implant. Or bring other properties. Similarly, the geometry, size, depth and / or position of the pocket below a particular position also has other properties of the implant under that position, such as tensile strength, tear strength, compressive strength and extensibility ( Affects (extensible or elastic) and / or identifies it. Thus, the pocket configuration can be adapted or designed to alter the properties of the implant at various locations. FIG. 15 shows various configurations of the internal pockets of the implant core.

If there is an implant pocket, the desired configuration can be achieved in any suitable manner, depending on the type of implant, the materials used, the desired characteristics and other factors. Can be different. One aspect of constructing the implant is by the use of injection molding, where the mold cavity is the geometry of the desired pocket so that there are pockets or voids within the molded implant when the structure is removed. It may include removable structures in shape. Commonly used injection molding methods using the core, cavity surface A and cavity surface B can be employed. Dual or multiple extrusions, 3D printing and other methods can also be used to make the implant structures described above.

The specific singular or plural materials employed for the implant are that they are biocompatible as standard and have the desired properties (eg, hardness, tensile strength) in the desired range described herein for the implant. It is not particularly limited here as long as it can be produced so as to have 1 or more, 2 or more, 3 or more, 4 or more, or all of them (strength, tear strength, compressive strength and / or extensibility). Thermosetting materials, thermoplastic materials, elastomers or combinations thereof may be employed. Useful thermoplastic materials include nylon, polyethylene, polypropylene and polystyrene, useful thermosetting materials include various forms of epoxy and phenolic resins, and suitable thermosetting materials include various gel colloids. Can include. Silicone and polyurethane can be particularly useful materials depending on the type of implant. Particularly suitable materials include foams and include solid or semi-solid closed cell foams such as those consisting of urethane, silicone or mixtures thereof.

Particularly suitable configurations for various implants include those comprising a layer having a layer thickness that varies over one or more dimensions of the implant. Another suitable configuration is one in which the amount of material used in the implant is varied over one or more dimensions in a gradient due to varying or altered honeycomb structures and the like. By reducing the layer thickness, perhaps in the honeycomb structure over the length of the implant, or by having more voids, the implant resembles the innate tissue and / or increases the size of the body part or improves its appearance. Hardness or other properties can be modified to allow normal physiological operation. In other embodiments, the implant may comprise one or more biocompatible materials having both linear and radial compression capacities. It can also assist in tissue expansion, allowing implants to resemble innate tissue and / or increase the size of body parts or improve their appearance while allowing normal physiological movements. Can contribute.

The specific properties of the implant may vary depending on the materials used, their placement and composition, eg, the geometry, size, depth or position of the pocket, if present. In one embodiment, the implant comprises one or more biocompatible materials, the specific location and / or material of the implant from about 0, about 10, about 20 or about 30 on the Shore A scale according to ASTM D2240-15. It has a durometer range of up to about 70, up to 60, up to 50 or up to 40 durometers.

Other useful properties of the implant that may be specified or desired to be constructed by the material may include extensibility, tensile strength, tear strength, compressibility or extensibility. Specifically, useful implant embodiments may comprise one or more biocompatible materials, wherein the specific location and / or material employed in the implant is at least about 200 psi, according to ASTM D421-06. It has tensile strengths from at least about 300 psi or at least about 350 psi to up to about 1000 psi, up to about 800 psi, up to about 700 psi or up to 600 psi. Similarly, the implant may comprise one or more biocompatible materials, the specific location and / or material used in the implant being at least about 400%, at least about 500%, at least according to ASTM D421-06. It has extensibility from about 600%, at least about 700% or at least about 800% to about 1200%, about 1100% or about 1000%. Similarly, the implant may comprise one or more biocompatible materials, the specific location and / or material used in the implant being at least about 40 pounds / inch (ppi) by ASTM D624, at least about 50. Pounds / inch (ppi), at least about 60 pounds / inch (ppi), at least about 70 pounds / inch (ppi) or at least about 80 pounds / inch (ppi) to about 200 ppi, about 130 ppi, about 120 ppi or about 110 ppi Has tear strength. The implants of the invention may also comprise one or more biocompatible materials, wherein the specific location and / or material employed in the implant is at least 0, at least 5, at least 10 or at least 15 to about 20. Has compression and / or elongation of up to% or about 25%. Compression can be tested, for example, by ASTM D395-03.

In another embodiment of the invention, the implant may comprise one or more biocompatible materials, wherein the specific location and / or material employed in the implant is at least one of the above properties, at least. It has two, at least three, or at least four or more.

Implants may be equipped with additional materials depending on the desired properties and application. For example, the implant may have a hydrophilic or hydrophobic agent inside or outside the implant. In one specific embodiment, the implant has an external hydrophilic agent such that the implant is at least partially resistant to bacteria, viruses, etc. in that bacteria, viruses, etc. cannot adhere to the surface. Such hydrophilic agents are not particularly limited and depend on the application. Thus, they can be selected from any compatible material and applied in appropriate amounts to achieve the desired effect.

Other suitable additives for the inside and / or outside of the implant include heat-dissipating and / or endothermic materials. Thus, the implant or portion of the implant can be made to be exothermic or endothermic based on exposure to one or more irritants.

As mentioned above, the invention is broadly applicable to any number of types of implants and / or prostheses or other medical devices. Specific embodiments may be particularly applicable to penile implants, testicular implants, female incontinence implants, thoracic implants, or similar implants and devices. More specifically, the present invention may be particularly applicable to those applications in which tissue expansion is desired. Such applications are not limited to, for example, when the implant is for humans or is placed in humans, for example, the desired tissue dilation approaches the urethral meatus, scaphoid fossa or bladder neck. Includes applications. Particularly suitable applications may include, for example, those in which the implant can be a penile implant, a male or female incontinence implant or plug or a chest implant. Of course, the method of placing, mounting, inserting and / or adopting the implant of the present invention will vary depending on the specific type of implant and the anatomy of the human or animal in which it is adopted. In most cases, conventional known surgical techniques or concepts can be employed in a given implant. Hereinafter, specific embodiments of the orthopedic penis implant will be described.

Specific Embodiments of Penis Implants The following specific embodiments disclosed relate to orthopedic penis implants and transplantation methods. However, it should be understood that the above concepts, materials, properties, fabrication methods and other descriptions apply similarly to orthopedic penile implants. Similarly, the concepts, materials, properties, fabrication methods and other descriptions specific to the penile implant embodiments described below are also applicable to many other types of implants and / or prostheses.

FIG. 8 shows a cross section of the anatomy of the innate penis consisting of several distinguishable sites. The glans penis is commonly referred to as the head of the penis. The skin 16 is the outer layer of the penis. The corpus cavernosum 10 is two sea-surface erectile tissues that are synonymous with the dorsal side of the penis, which causes an erection when filled with blood. The corpus cavernosum 15 is a single marine tissue that constitutes the medial ventral side of the penis surrounding the urethra 18 from the bladder neck to the glans penis, which is also filled with blood during erection but does not contribute to erection. The pair of corpus cavernosum 10 and urethral corpus cavernosum 15 are included in the duct of the deep penile fascia called the back fascia. The back fascia 20 also surrounds the deep dorsal vein 22 of the penis, a pair of dorsal arteries of the penis and the dorsal nerve 24.

An orthopedic penis implant may have a body with a longitudinal axis of selected longitudinal length along the longitudinal axis of the penis. The body can have any length and any diameter or width. In one embodiment, the body may have a cylindrical cross section. In other embodiments, the body may have an elliptical or oval cross section. In yet another embodiment, the body may have a cross section of any shape. The body has an outer surface and an inner surface. The body can be formed as an integral part. The cross section perpendicular to the longitudinal axis of the body has a layer thickness that thins in both opposite directions from the maximum thickness along the dorsal centerline to the minimum thickness along the ventral edge forming the ventral opening. Can be. The ventral edge can be a straight or wavy edge. The body can be open at both the near end (closest to the base of the penis) and the far end (closest to the glans penis) on the opposite side.

The body may have a constant layer thickness in a longitudinal direction extending from the near end of the body to the starting point of the distal portion, at the starting point of the proximal portion, the layer thickness is the starting point of the distal portion. It becomes thinner from the far end of the main body. Since the constant layer thickness is more consistent with the natural anatomy of the penis, the constant layer thickness that extends along the longitudinal length of the body from the near-end to the distal start point becomes thinner. It is more suitable than the thickness of the layer. The distal part has a layer thickness that thins only in the short part near the far end of the body (closest to the glans penis). The body may be rounded, chamfered, or pillow-shaped with all edges and corners. The implant is configured to have a size and shape suitable for subcutaneous implantation between the exodermis and the adjacent back fascia. Upon transplantation, the device can extend from the base of the penis at its near end to the glans penis at its far end.

The body may be any kind of polymer, elastomer, rubber, composite or any other material that reproduces in shape, appearance, elasticity, compressibility, texture and feel as close as possible to the natural human anatomy. It can be made from spongy, flexible or compressible materials. The implant body material will be flexible, supple and compressible to best mimic normal penile tissue in a relaxed state while producing improved relaxed penile length and perimeter dimensions. In one embodiment, the body can be made of silicone. In other embodiments, the body can be made of polyurethane. The softness of the material forming the body of the implant can have a Shore A softness of less than 25, less than 20, less than 15, less than 12, or more preferably less than 10. Shore durometers measure the hardness of materials, usually polymers, elastomers and rubbers. High numbers on that scale indicate higher indentation resistance and therefore harder materials. Lower numbers indicate softer, more compressible or more flexible materials. There are several scale durometers used for materials with different properties. The two most common scales that use slightly different measurement systems are the ASTM D2240 Type A and Type D scales. The A scale is for soft materials, while the D scale is for hard materials.

If desired, mesh tabs about 1 to about 2 cm in length can be placed via a length of lateral margin separated by about 0.75 cm to about 1.25 cm. The body may have one or more embedded tabs overhanging from its near end, eg, a mesh tab, and one or more embedded mesh tabs overhanging from its far end. The mesh tabs may extend beyond the near and far ends to any distance. For example, embedded mesh tabs may synonymously overhang (on both sides) up to 0.5 cm beyond the far end, up to 1.0 cm beyond the far end, up to 1.5 cm beyond the far end, or more. good. The embedded mesh tabs may synonymously project over the near end to 1.0 cm, beyond the near end to 1.5 cm, and beyond the near end to 2.0 cm or more. The mesh tab may be of any shape and size, for example a rectangle or square with right angles on each side, with the body at both the far and near ends against the fibrous sheath of the back fascia and corpus cavernosum. Provided as a functional means for suturing, it supports the body to hold it in place and prevents longitudinal and / or rotational movement. The mesh tabs are configured to undergo tissue endoculture and can be made of any material and mesh size as long as they assist and promote innate tissue endoculture. For example, the mesh can be a polyurethane mesh. Alternatively, the mesh may be a reconstructive general plastic or other type of material commonly used in urological surgery as understood by those skilled in the art. Absorbent sutures may be used to secure the mesh tabs to the back fascia and the corpus cavernosum. The suturing method will be understood by those skilled in the art. The mesh tabs may be integrally formed with the body, embedded within the body, attached to it, attached between multiple layers of the body, or other attachments. It may be attached to the main body by a method. The mesh tabs are located at the near and far ends, as close to the ventral margin as possible. The mesh tab avoids sutures or tissue endoculture near the dorsal neurovascular bundle, which would pose a risk of denervation or vasculectomy of the penis both during transplantation and during any subsequent necessary explantation. As such, it is not located within or attached to the body along or near the dorsal centerline.

The body may have an antibacterial surface coating containing an antibacterial agent that suppresses the ability of microorganisms to grow on the surface of the body. For example, antibiotics or antibacterial agents may be coated on the surface or embedded in the implant material, which may potentially reduce the risk of bacterial infection of the implant. In one embodiment, the body may be immersed in an antibiotic or antibacterial agent that coats the surface. In other embodiments, the body may be impregnated with an antibiotic or antibacterial agent during body formation. The antibiotic coating or impregnation of the body will be in accordance with bioprosthesis standards as understood by those of skill in the art. Any type of antibiotic or antibacterial agent can be used. For example, in certain embodiments, rifampicin and / or minocycline may be used.

FIGS. 1-7 show embodiments of the penis implant 100. FIG. 1 shows a perspective view of an embodiment of the penis implant 100. 2 and 7 show side views and cross-sectional views of embodiments of the penis implant 100, respectively. The implant 100 has a longitudinal axis and a cylindrical body 110 having a selected longitudinal length along the major axis of the penis. The cylindrical body 110 has an outer cylindrical surface 112 and a smaller inner cylindrical surface 114. 3 and 4 show a cross-sectional view perpendicular to the longitudinal axis of the cylindrical body 110. The cylindrical body 110 has a layer thickness that is thinned in the circumferential direction in both opposite directions from the maximum thickness along the dorsal center line 120 to the minimum thickness along the ventral edge 122 forming the ventral opening 124. The ventral edge 122 is shown as wavy, but may be a linear edge.

FIG. 5 shows a far-end view and FIG. 6 shows a near-end view of the penis implant 100. The cylindrical body 110 may be open at both the near end 116 (closest to the base of the penis) and the far end 119 (closest to the glans penis) on the opposite side. The body 110 may have a constant layer thickness in a longitudinal direction extending from the near end 116 of the body to the start point 117 of the distal portion 118, and the layer thickness is cylindrical from the start point 117 of the distal portion 118. It becomes thinner to the far end 119 of the main body 110. The distal portion 118 has a layer thickness that thins from the starting point 117 of the distal portion 118 to the far end 119 of the cylindrical body 110 (closest to the glans penis). The cylindrical body 110 may have pillow-shaped or rounded edges 128 at both the near end 116 and the far end 119. The implant 100 is configured to have a size and shape suitable for subcutaneous implantation between the integument 16 and the adjacent back fascia 20. The implant can extend from the base of the penis at its near end to the glans penis at its far end.

The cylindrical body 110 further includes an embedded mesh tab 128 located at its near end 116 and one or more embedded mesh tabs 128 located at its far end 119. The mesh tab 128 undergoes tissue endoculture and sutures the cylindrical body to the back fascia 20 at both the far end 119 and the near end 116 to hold the cylindrical body 110 in place and in the longitudinal and / or rotational direction. It is configured to provide a functional means to prevent the movement of the. Absorbent sutures may be used to secure the mesh tabs to the back fascia and the underlayer of the corpus cavernosum. The mesh tab 128 may be integrally formed with the cylindrical body 110, may be embedded in the cylindrical body 110, may be attached to the mesh tab 128, or may be fixed between a plurality of layers of the cylindrical body 110. Alternatively, it may be fixed to the cylindrical body 110 by another mounting method. The mesh tab 128 is located at the near end 116 and the far end 119 as close as possible to the ventral edge 122. The mesh tab 128 is along the dorsal centerline or along the dorsal centerline to avoid sutures or tissue endometrial near the dorsal neurovascular bundles 22 and 24, which would pose a risk of penile denervation or vasculectomy. It is not located in the main body 110 near it or cannot be attached to the main body 110.

The following methods can be used to implant orthopedic penile implants. Orthopedic penile implants can be placed by a scrotal or abdominal penile plastic incision with or without a related surgical drain placement without an abdominal incision. A scrotal or abdominal penile formation incision identifies the back fascia of the upper layer of the fibrous capillar of the corpus cavernosum, and soft tissue deposits are released by both obtuse and acute incisions. Penile vascular resection or sensory nerve resection by taking care to avoid the division of the back fascia along the dorsal lateral margin of the corpus cavernosum and to avoid damage to the underlying penile neurovascular bundle. Avoid danger. This incision causes the glans penis to degenerate caudally, inverting the penile root and allowing direct examination and additional incision of the distal penile root. The distal implant margin containing the mesh tab is then secured laterally to the dorsal neurovascular bundle using resorbable sutures to ensure safe and proper placement of the implant. Similarly, resorbable sutures are used to secure the proximal margin of the implant ventrally, allowing tissue endoculture at each location of the implant in all quadrants. This further secures the implant in the desired position and reduces the risk of implant movement, misalignment and erosion. This surgical approach also facilitates the symmetrical ventral placement of the implant laterally to the urethral margin by direct examination, and also makes the implant more concealed and comfortable thinning as well as proper placement of the implant. Ensure lateral implant margin. Wounds and implants can be extensively washed with aqueous antibiotics, and absorbable sutures also achieve and confirm hemostasis before the subcutaneous tissue is rejoined. The scrotal skin is similarly rejoined with an absorbent suture that provides a two-layer closure. Care should be taken to avoid penile ischemia by loosely wrapping the penile root with gauze and elastic glue. Patients may, at the surgeon's discretion, be discharged on the same day after a short recovery period, with instructions on when to remove the bandages 24 hours, 48 hours or 72 hours after discharge. Subsequent routine irrigation of the wound may be performed. At the surgeon's discretion, it is usually advised to avoid sexual intercourse for a period of 1 month or preferably 6-8 weeks after surgery. Patients are usually advised to come to the hospital for postoperative examination at intervals of semi-weekly, weekly or biweekly, at the discretion of the surgeon, for approximately 1 or 2 months after surgery.

Other methods of implanting orthopedic penile implants may be those taught by US Pat. No. 4,202,530, which is incorporated herein by reference in its entirety.

Subsequently, the inflatable penile implant that cures erectile dysfunction is deeper with respect to the orthopedic penile implant without significant physical modification to the orthopedic penile implant or without defeating the intended purpose of the orthopedic penile implant. , Can be implanted in the cancellous penis. Similarly, placement of an orthopedic penile implant after placement of an inflatable penis implant is possible with any of the surgical approaches described above. Advantageously, after placement of the orthopedic penile implant, subject to the use of resorbable sutures, the elasticity of the implant body, and the partial use of a mesh attachment with the dorsal centerline neurovascular bundle removed. There are no restrictions on the erection of the penis.

9A and 9B show embodiments of penis implants in perspective views of each side. As shown in FIG. 10, like the other implants here, penile implants can be made in a wide range of sizes and dimensions. Advantageously, the layer thickness can vary over the length of the implant, and / or the geometry and composition are adjustable in the pockets mentioned above. The hardness can be varied across the various dimensions of the implant by reducing the material with a thinner layer and / or by adding more pockets. Thus, hardness and other properties may vary from proximal to distal and vice versa, for example, the proximal part has a low density while the distal part has a dense honeycomb structure. obtain. This helps, for example, to impart augmentation while preserving physiological sensations and functions. That is, the penis and other implants of the present invention can mimic much softer tissue than, for example, other implants that may employ a bag-like or balloon-like exterior whose cavity is filled with a liquid material. On the other hand, the implant of the present invention may be composed of a single material composed of pockets for adjusting properties.

The penis and other implants can be attached in any suitable manner. As mentioned above, in certain embodiments, the penis implant may include a tab for suturing the penis or other implant to the body. And if adopted, the tab may be located at any suitable position and may be composed of any biocompatible material. FIG. 11 shows typical mesh tab positions for the penile implants shown in FIGS. 9A and 9B, and FIG. 13 shows exemplary types of mesh materials that may be employed.

As detailed above, an implant, such as a penile implant, may be composed of a material that exhibits a different range of properties, such as durometer, elongation, tension, tear, etc., at one or more different locations of the implant. FIG. 12 shows the shore hardness scale and typical properties of various implants such as penile implants. 14A, 14B and 14C show embodiments of penile implant location, method and dimensioning. Of course, if desired, one or more of the various other features can be incorporated into the penis or other implant as long as it does not substantially interfere with its function. A non-limiting enumeration of such features may include ribs, humps, horny organs, grooves, radiodensity properties, fluorescence or any other irradiation properties.

Embodiments of general-purpose implants 1. An implant suitable for a desired animal or human body part or part thereof, comprising one or more biocompatible materials, wherein the one or more materials tissue without substantially impairing normal anatomical movements. Implants selected or configured to promote dilation.

2. 2. The implant comprises one or more biocompatible materials selected or configured such that the measurement characteristics of the implant in the first position differ from the same measurement characteristics of the implant in the second position. Implants.

3. 3. The measurement characteristic includes the following characteristics: (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength and (5) extensibility, which are one or more of the implants of the second embodiment. ..

4. The measurement characteristic includes the following characteristics: (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength and (5) extensibility, which are two or more of the implants of the third embodiment. ..

5. The implant is an implant of embodiment 1 comprising one or more biocompatible materials having both linear and radial compression capacities.

6. The implant of embodiment 1 comprises one or more biocompatible materials having a durometer range of about 0 to about 70 durometers on the Shore A scale.

7. The implant is the implant of embodiment 1 comprising one or more biocompatible materials having a tensile strength of about 200 psi to about 800 psi.

8. The implant is an implant of embodiment 1 comprising one or more biocompatible materials having an extensibility of about 600% to about 1200%.

9. The implant according to embodiment 1 comprises one or more biocompatible materials having a tear strength of about 40 pounds / inch (ppi) to about 130 ppi.

10. The implant is an implant of embodiment 1 comprising one or more biocompatible materials having a compression and extension rate of up to about 25%.

11. The implants have the following: (1) durometer range of about 0 to about 70 durometers, (2) tensile strength of about 200 psi to about 800 psi, about 600% to about 1200% extensibility, (3) about 40 ppi to about. The implant of embodiment 1 comprising one or more biocompatible materials having a tear strength of 130 ppi and (4) two or more of compression and extension rates up to about 25%.

12. The implant is the implant of Embodiment 1, further comprising a hydrophilic agent.

13. The implant is the implant of Embodiment 1, comprising a layer having a varying layer thickness.

14. The implant of embodiment 1 is configured such that the one or more materials include one or more internal pockets in which one or more of the following: geometric shapes, sizes, depths or positions change.

15. The one or more internal pockets are as follows: (1) to reduce the stiffness of at least a portion of the implant, (2) to reduce the total weight of the implant, (3) elasticity of at least a portion of the implant. Embodiments configured to provide one or more of (4) increasing the extensibility of at least a portion of the implant, or (5) increasing the compressibility of at least a portion of the implant. 14 implants.

16. The implant of embodiment 14, wherein the internal pocket comprises one selected from compression pockets, extension pockets, or both.

17. The implant of embodiment 16 wherein the internal pocket allows up to 500% elongation compared to the same implant substrate without an internal pocket (eg, the same polymer of the same shape).

18. The internal pocket is an implant of embodiment 1 comprising a honeycomb structure design.

19. The biocompatible material is the implant of Embodiment 1, comprising a material capable of dissipating heat.

20. The biocompatible material is the implant of Embodiment 1, comprising a material having an endothermic capacity.

21. The configuration comprises an internal pocket and one or more biocompatible materials include: (1) a durometer range of about 10 to about 70 durometers, (2) a tensile strength of about 200 psi to about 800 psi, about 600% to about. The implant of embodiment 1 having 1200% extensibility, (3) a tear strength of about 40 ppi to about 130 ppi, and (4) a compression and extension rate of up to about 25%.

22. The implant is the implant of embodiment 1, which is a penis implant, a testicular implant, a female incontinence implant, or a thoracic implant.

23. The tissue dilation is an implant of embodiment 1 configured to be present near the urethral meatus, tubule or bladder neck when the implant is placed in a human.

Embodiments of penis implants 1. It ’s a penis implant,
It has an outer and inner surface as well as a longitudinal axis and comprises a body of selected longitudinal length along the major axis of the penis, said body.
Perpendicular to the longitudinal axis of the body having a layer thickness that thins in both opposite directions, starting from the maximum thickness along the dorsal centerline and down to the minimum thickness along the ventral edge forming the ventral opening. With a nice cross section
The penis implant comprises one or more biocompatible materials selected or configured to promote tissue expansion.

2. 2. The penis implant of Embodiment 1, wherein the one or more biocompatible materials are configured to include one or more internal pockets in which one or more of the following: geometric shapes, sizes, depths or positions change. ..

3. 3. The one or more internal pockets are as follows: (1) to reduce the stiffness of at least a portion of the implant, (2) to reduce the total weight of the implant, (3) elasticity of at least a portion of the implant. Embodiments configured to provide one or more of (4) increasing the extensibility of at least a portion of the implant, or (5) increasing the compressibility of at least a portion of the implant. 2 penis implants.

4. The internal pocket is a penis implant of Embodiment 2, comprising a honeycomb structure design.

5. The penis implant of Embodiment 1 comprising one or more biocompatible materials selected or configured such that the measurement characteristics of the penis implant in the first position differ from the same measurement characteristics in the second position of the implant. ..

6. The measurement characteristics include the following characteristics: (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength, and (5) extensibility, which are one or more of the following characteristics, that is, the penis of the fifth embodiment. Implant.

7. The penis implant of embodiment 6, wherein the measurement characteristic of hardness is different from the second position of the implant at the first position of the penis implant.

8. The penis implant of embodiment 7, wherein the measured properties of hardness differ from the near end of the implant to the far end of the implant.

9. The penis implant of Embodiment 2, wherein the one or more internal pockets are configured to result in one or more characteristic changes from the near end of the implant to the far end of the implant.

10. The penis implant of Embodiment 3, wherein the one or more internal pockets are configured to provide a change in stiffness from the near end of the implant to the far end of the implant.

11. The penis implant of Embodiment 1 comprising one or more tabs configured to suture the body.

12. The tab is a penis implant of embodiment 11 configured to suture the back fascia at both the far and near ends to undergo tissue endothelium.

13. The penis implant of embodiment 11, wherein the one or more tabs are implantable tabs that project beyond the near end of the body and beyond the far end of the body.

14. The one or more tabs are the penis implants of embodiment 11, comprising a mesh material.

15. The tab is a penis implant of embodiment 12, configured to employ an absorbent suture.

16. The penis implant of Embodiment 1, further comprising an antibiotic or an antibacterial agent.

17. The penis implant of Embodiment 1 further comprising ribs, humps, horny organs, grooves, radiodensity properties, fluorescence or other irradiation properties.

The subject matter described in the claims should not be limited in scope by the specific embodiments described herein. Naturally, in addition to those described herein, various modifications of the invention will be apparent to those skilled in the art from the above description. Such modifications are intended to be within the scope of the appended claims.

Claims (16)

An implant suitable for a desired animal or human body part or portion thereof, comprising one or more biocompatible materials, said one or more of which is tissue without substantially impairing normal anatomical movements. Implants selected or configured to promote dilation. The implant is a penile implant that has an outer and inner surface as well as a longitudinal axis and has a body of selected longitudinal length along the longitudinal axis of the penis.
The main body has a layer thickness that is thinned from the maximum thickness along the dorsal center line to the minimum thickness along the ventral edge forming the ventral opening in both opposite directions in the circumferential direction. With a cross section perpendicular to the direction axis,
The implant according to claim 1, wherein the one or more materials include an internal pocket configured such that the measurement characteristics of hardness differ from the near end of the implant to the far end of the implant. The implant comprises one or more biocompatible materials selected or configured such that the measurement characteristics of the implant in the first position differ from the same measurement characteristics of the implant in the second position. Or the implant according to 2. The measurement characteristic comprises one or more of the following characteristics: (1) hardness, (2) tensile strength, (3) tear strength, (4) compressive strength and (5) extensibility, claim 1 or 2. The implant described in. The implant according to claim 1 or 2, wherein the implant comprises one or more biocompatible materials having both linear and radial compression capacities. The implant has the following characteristics: a durometer range of about 0 to about 70 durometers on the Shore A scale, a tensile strength of about 200 psi to about 800 psi, an extensibility of about 600% to about 1200%, about 40 pounds / inch (ppi). The implant according to claim 1 or 2, comprising one or more biocompatible materials having a tear strength of ~ about 130 ppi, or one or more of compression and extension rates up to about 25%. The implants have the following: (1) durometer range of about 0 to about 70 durometer, (2) tensile strength of about 200 psi to about 800 psi, (3) about 600% to about 1200% extensibility, (4) about. The implant according to claim 1 or 2, comprising one or more biocompatible materials having a tear strength of 40 ppi to about 130 ppi, and (5) two or more of compression and extension rates up to about 25%. The one or more biocompatible materials are further configured to include one or more internal pockets in which one or more of the following: geometric shapes, sizes, depths or positions change. The implant according to 2. The one or more internal pockets are as follows: (1) to reduce the stiffness of at least a portion of the implant, (2) to reduce the total weight of the implant, (3) elasticity of at least a portion of the implant. , (4) increasing the extensibility of at least a portion of the implant, or (5) increasing the compressibility of at least a portion of the implant. 7. The implant according to 7. The implant according to claim 1 or 2, comprising an internal pocket with a honeycomb structure design. The implant according to claim 1 or 2, comprising an internal pocket configured to provide one or more characteristic changes from the near end of the implant to the far end of the implant. The implant according to claim 1 or 2, comprising an internal pocket configured to provide a change in stiffness from the near end of the implant to the far end of the implant. The implant according to claim 1 or 2, comprising one or more tabs configured to be sutured to the body. 12. The implant of claim 12, wherein the one or more tabs are attached to the body of the implant. 12. The implant of claim 12, wherein the one or more tabs comprises a mesh material. The implant according to claim 1 or 2, further comprising an antibiotic or an antibacterial agent.

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